BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 15798737 · Received November 15, 2022

    Report

    Report Number
    2025587-2022-03192
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    September 16, 2022
    Report Date
    November 15, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: COSTA G, ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE LATEST-ITERATION SELF-EXPANDING OR BALLOON-EXPANDABLE VALVES: THE MULTICENTER OPERA-TAVI REGISTRY. JACC: CARDIOVASCULAR INTERVENTIONS. (B)(6) 2022;S1936-8798(22)01710-1. DOI: 10.1016/J.JCIN.2022.08.057. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT PRO (PMA# P130021, PRODUCT CODE NPT), EVOLUT PRO+ (PMA# P130021, PRODUCT CODE NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH THE LATEST ITERATIONS OF SELF-EXPANDING (SE) AND BALLOON-EXPANDABLE (BE) VALVES. ALL DATA WAS COLLECTED FROM AN INTERNATIONAL MULTI-CENTER REGISTRY BETWEEN SEPTEMBER 2017 AND JANUARY 2022. AFTER PROPENSITY SCORE MATCHING, 683 MATCHED SETS OF PATIENTS TREATED WITH A BE TAVR SYSTEM (EDWARDS SAPIEN 3 ULTRA) OR A SE TAVR SYSTEM (MEDTRONIC EVOLUT PRO OR PRO+) WERE COMPARED. THE EVOLUT PRO/PRO+ GROUP WAS PREDOMINANTLY FEMALE WITH A MEDIAN AGE OF 81.6 YEARS. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. IN THE EVOLUT PRO/PRO+ GROUP, 13 ALL-CAUSE DEATHS OCCURRED WITHIN THIRTY DAYS OF TAVR. NONE OF THE DEATHS WERE DIRECTLY ATTRIBUTED TO MEDTRONIC PRODUCT. IN THE EVOLUT PRO/PRO+ GROUP, ADVERSE EVENTS INCLUDED: RECAPTURING/REPOSITIONING THE VALVE PRIOR TO FULL DEPLOYMENT (1 ATTEMPT = 84 CASES, 2 ATTEMPTS = 2 CASES, 3 ATTEMPTS = 2 CASES); TWO TRANSCATHETER VALVES IMPLANTED DURING THE PROCEDURE; ANNULAR RUPTURE; CORONARY OBSTRUCTION; STROKE (DISABLING OR NON-DISABLING); MYOCARDIAL INFARCTION; PERMANENT PACEMAKER IMPLANTATION; ELEVATED TRANSPROSTHE TICMEAN GRADIENT (= 20 MM HG); PARAVALVULAR REGURGITATION (MILD TO SEVERE); AND REHOSPITALIZATION FOR HEART FAILURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757763 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Life Threatening| S| H| R